MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO; HOLDER, NEEDLE, GASTROENTEROLOGIC

Model Number M0068311250

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 01/10/2018

Event Type  malfunction  

Event Description

Surgeon using capio suturing device when the bullet on the suture came off.The bullet was recovered from the end of the device.A new device was obtained.

• Brand Name: CAPIO
• Type of Device: HOLDER, NEEDLE, GASTROENTEROLOGIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline ave. n; saint paul MN 55112
• MDR Report Key: 7218355
• MDR Text Key: 98225656
• Report Number: 7218355
• Device Sequence Number: 1
• Product Code: FHQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: M0068311250
• Device Catalogue Number: M0068311250
• Device Lot Number: 20706637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 57 YR
• Patient Weight: 89